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Global Quality Manager & RP - Health Hub

Global Quality Manager & RP - Health Hub

Slough, Berkshire

Competitive Salary & excellent benefits package

 

The primary responsibility of the Health Hub Quality Manager & RP is to provide leadership for excellence in Quality and Compliance of all Health products and processes within the supply/distribution chain in the Global Health Hub, and for the effective management of the Health Hub Quality team. 

 

This position is required to act as the Responsible Person and Responsible Person for Imports on the Wholesale Dealers Licence of the Health Hub to ensure compliance with the EU GDP (2013/C 343/01).

 

The Health Hub Quality Manager will be required to:

  • Build collaborative relationships with key stakeholders, business partners and external suppliers.
  • Influence key business partners and stakeholders to ensure any risks to the Health Hub are addressed in a timely manner.
  • Have the authority to escalate any compliance risks to the licence holder directly. 

 

Responsibilities / Accountabilities

 

Local Quality Management System (QMS)

  • Responsible to lead the Health Hub Quality Team to assure compliance to the regulatory requirements, Marketing Authorisation and Wholesaler Distribution Authorisation.
  • Responsible to ensure the following RP and RPi activities are being performed in line with the GDP regulations (2013/C 343/01) and UK regulatory expectations:
    • ensuring that a quality management system is implemented and maintained;
    • focusing on the management of authorised activities and the accuracy and quality of records; 
    • ensuring that initial and continuous training programmes are implemented and maintained;
    • coordinating and promptly performing any recall operations for medicinal products; 
    • ensuring that relevant customer complaints are dealt with effectively; 
    • ensuring that suppliers and customers are approved; 
    • approving any subcontracted activities which may impact on GDP; 
    • ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place; 
    • keeping appropriate records of any delegated duties; 
    • deciding on the final disposition of returned, rejected, recalled or falsified products; 
    • approving any returns to saleable stock;
    • ensuring that any additional requirements imposed on certain products by national law are adhered to (e.g. RPi checks etc)
  • Provide leadership on continuous improvement projects, quality initiatives, etc. as established by corporate Quality Management.
  • Collaborate and influence other functions to develop and maintain all relevant procedures in line with the requirements of the Global QMS & associated policies, relevant codes of practice and GDP.
  • Audit/Inspection Management – Ensure that processes are in place to assess the adequacy and effectiveness of the local QMS. 
  • Ensure that an effective supplier approval is in place for logistics providers.

 

The individual should understand…

  • the role of the local competent authority in the licensing of medicines;
  • the current European regulations related to Human Medicines Regulations in relation to wholesale distribution (EU GDP 2013/C 343/01);
  • the current European Pharmaceutical Directive related to Wholesale Distribution of Medicinal Products

 

Interface with Global/Local Quality

  • Work with global and local teams to ensure implementation of appropriate controls to ensure consistent quality of products

 

Co-ordinate inspections 

  • Responsible to co-ordinate and host external inspections by External Authorities, third-parties and RB Corporate group.
  • Responsible for follow ups and responses after external inspections.

Knowledge and experience
 

  • At least 5 years’ experience working in a quality compliance function in Healthcare, Pharmaceutical, or Medical Device related industry.
  • Experience in developing and maintaining a robust QMS in a Healthcare, Pharmaceutical, or Medical Device related industry.
  • Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.
  • Good understanding of regulatory, GMP and GDP requirements relevant to a regulated product e.g. EU GMP, EU GDP, WHO, PIC/S, CFR 21 Part 210/211.
  • Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
  • Influencing skills in areas with no direct reporting authority.
  • Strong interpersonal and communication skills.
  • Auditing skills, appropriate qualifications in auditing an advantage.
  • Language skills appropriate to the assigned country and/or regional cluster.

 

As Responsible Person:

  • Autonomy
    • take responsibility for planning and developing courses of action, including responsibility for the work of others
    • exercise autonomy and judgement within broad but generally well-defined parameters
  • Management & Leadership
    • develop and implement operational plans for their area of responsibility
    • manage diversity & discrimination issues
    • provide leadership for their team
  • Working with others
    • develop and maintain productive working relationships with colleagues and stakeholders
    • allocate and monitor the progress and quality of work within their area of responsibility
    • provide learning opportunities for colleagues
  • Personal development
    • manage their professional development by setting targets and planning how they will be met
    • review progress towards targets and establish evidence of achievements
  • Communication
    • report to management, the marketing authorisation holder and the MHRA any suspicious events they
    • become aware of
    • put across ideas in clear and concise manner and present a well-structured case
    • communicate complex information to others
  • Business Awareness
    • understands the business environment in which the company operates
    • has an appreciation of the industry sector and competitors
  • Customer Awareness
    • understands the customer base and is aware of customer requirements.

 

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 


Job Segment: Medical Device, Medical, Healthcare

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